COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05209009

Volker Gerdts

Not reported

2022-01-26

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: generally healthy male and female adults aged 18 years of age or older at the time of signing the informed consent form; good general health as determined by screening evaluation not greater than 30 days before injection of first dose; note: participants who are overtly healthy as determined by medical evaluation or are considered medically stable according to the judgment of the investigator. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment, and/or hospitalization within the entire study period is not anticipated. also, the participant appears likely to be able to remain in follow-up through the end of protocol-specified period. mild to moderate well-controlled comorbidities are allowed. if female of child-bearing potential and heterosexually active, practice of adequate contraception for 30 days prior to injection, negative pregnancy test on the day of injection, and agreement to continue adequate contraception until 180 days after the second injection; male participants are eligible to participate in the study if they agree to the following requirements during the study period and for at least 28 days after the last injection of study dose, i.e., o be abstinent from any heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle. or o must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. in addition to male condom use, a highly effective method of contraception should be considered in women of child-bearing potential partners of male participants. and o must refrain from donating sperm; and written informed consent, after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee and pass the "test of understanding" (up to 3 attempts). for participants who cannot read or write, the consent must be witnessed by a literate third party not involved in study conduct.

presence of any febrile illness or any known or suspected acute illness on the day of any immunization; clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture. any condition, which in the opinion of the investigator, may make the participant inappropriate for the study; receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; presence of autoimmune disease; receipt of any investigational drug within 6 months; receipt of any non-covid-19 authorized vaccines within 2 weeks of receiving study dose injection; receipt of any authorized covid-19 vaccine prior to study enrollment; receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; current anti-tuberculosis therapy; history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator; and pregnant and breastfeeding females.

2

University of Saskatchewan

18

100

Uganda

Healthy volunteers

N/A

150

Assessment of the safety and tolerability of COVID-19 vaccine (COVAC-2) following two consecutive injections (28 days apart) in generally healthy volunteers

None

Phase 2

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